EDC Plus Instructions for Use Ver 4.00

Van Vliet Medical Supply B.V. Antennestraat 60 1322 AS Almere The Netherlands

These instructions for use apply to EDC Plus drying cabinets with serial numbers commencing from: NG816046 Use of the endoscope drying and storage cabinet in any manner other than as described in these instructions for use can result in damage to the EDC Plus and/or injury to personnel or damage to endoscopes. Van Vliet Medical Supply B.V. is not responsible if the EDC Plus is used by unauthorised persons or for the damage that might be caused as a result.

EDC Plus Instructions for use

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Version 4.00

Contents 1

2

3

4

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General information ... 5 1.1 User instructions ... 5 1.2 Signal words ... 5 1.3 Conventions throughout this document ... 5 Introduction ... 6 2.1 Safety Information... 6 2.2 Intended use ... 6 2.3 General warning notices ... 7 2.4 Product liability ... 8 2.4.1 EN 16442:2015 “Controlled environment storage cabinet for disinfected thermolabile endoscopes” ... 8 Product description ... 9 3.1 General description... 9 3.2 Working principal of drying ... 11 3.3 Default settings ... 11 3.4 Delivery content ... 12 3.5 Accessories ... 12 3.6 Construction of the EDC Plus ... 13 3.6.1 EDC Plus expansions ... 15 Use ... 16 4.1 Connecting the adapter to the EDC Plus ... 16 4.2 Preparing endoscopes for EDC Plus... 17 4.3 Inserting the endoscopes into the EDC Plus (model B) ... 17 4.4 Inserting the endoscopes into the EDC Plus (model D)... 18 4.5 Removing the endoscope from the EDC Plus (model B) ... 18 4.6 Removing the endoscope from the EDC Plus (model D)... 18 4.7 Touch panel ... 19 4.7.1 Endoscope information ... 20 4.7.2 Resetting an error message ... 22 Documentation ... 23 5.1 RFID tag ... 23 5.2 RFID card ... 24 5.3 RFID reader ... 24 5.4 Documentation software ... 24 5.5 Printer ... 25 5.5.1 Print-out STAR paper printer ... 26 5.5.2 Print-out OD9 label printer ... 27 Maintenance ... 28 6.1 Regular maintenance intervals... 28 6.2 Internal and external cleaning of the EDC Plus ... 28 6.2.1 Outer surfaces of the EDC Plus ... 28 6.2.2 Glass doors ... 29 6.2.3 Door handles ... 29 6.2.4 Touch panel ... 29 6.2.5 Inner surfaces and accessories ... 29 6.2.6 Drip tray... 29 6.3 Adapter ... 30

EDC Plus Instructions for use Version 4.00

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6.3.1 Cleaning and disinfection by wiping ... 30 6.3.2 Manual reprocessing ... 30 Troubleshooting ... 30 7.1 Troubleshooting guide ... 31 Compatible equipment ... 32 8.1 EDC Plus and ADU Plus ... 32 8.2 Endoscopes ... 32 8.3 Endoscope holder ... 32 8.4 Instrument baskets ... 32 8.5 Endoscope adapter... 33 8.6 Holder for endoscope connector ... 34 8.7 RFID tag ... 35 8.8 RFID cards ... 35 8.9 Printer ... 35 8.9.1 OD9 label printer ... 35 8.9.2 STAR paper printer ... 35 8.10 Documentation software ... 35 Technical data ... 36 Manufacturer and distributor... 37

EDC Plus Instructions for use Version 4.00

1 General information This product is under constant development. Even though all efforts are made to always update this adapter manual, we reserve the right to change technical data and equipment without previous announcement. This product is a non-medical device. All rights reserved.

1.1 User instructions

These instructions for use contain essential information on using these products safely and effectively. The complete set of instructions for use for these products consists of the following documents: • EDC Plus instructions for use • EDC Plus adapter manual • EDC Plus accessory manual In addition, the instructions for use for the endoscopes to be reprocessed are needed for the reprocessing procedure. • Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. • If any required instructions for use are missing, immediately contact your local Olympus representative. • Keep the instructions for use in a safe, accessible location.

1.2 Signal words The following signal words are used throughout these instructions for use: WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. NOTICE Indicates a property damage message.

1.3 Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information. 1) A numeration indicates a sequence of actions. • Bullet points indicate the listing of data, options or objects.

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2 Introduction 2.1 Safety Information Before putting the devices into operation, read the instructions for use carefully to prevent injury to the user and damage to the devices. • The EDC Plus is designed exclusively for the applications specified in these instructions for use. • Before operating the EDC Plus, Olympus recommends that the operator ensures that the user obtains a training of safe operating and maintenance. Always clean and disinfect the EDC Plus and all accessories before use (refer to chapter 6). Carry out all activities with disinfected hands and using clean gloves. NOTICE Only trained staff is allowed to operate the EDC Plus with an age older than 18 years. NOTICE Installation, disposal and maintenance must be performed by appropriately qualified personnel of Olympus. Olympus will provide user training after installation of the EDC Plus. If you would appreciate any further support for regular training, please contact your local Olympus representative. For questions on the topics covered in these instructions for use or the operation or safety of the equipment, contact an Olympus representative. NOTICE The manufacturer do not held liable for damage caused by non-compliance with these safety precautions and warnings or by improper or incorrect use of the EDC Plus.

2.2 Intended use

The EDC Plus is produced for automatic exterior surface and channel drying as well as storage of cleaned and disinfected flexible medical endoscopes. WARNING Risk of injury to the patient Do not place endoscopes which are not cleaned and disinfected in the EDC Plus.

The EDC Plus is intended for vertical drying and storage the following compatible endoscopes: • Medical flexible endoscopes of Olympus, refer to EDC Plus adapter manual • Medical flexible endoscopes of other manufacturers, refer to EDC Plus adapter manual. WARNING Risk of injury to the patient Do not use the EDC Plus for any purpose other than its intended use.

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EDC Plus Instructions for use Version 4.00

2.3 General warning notices

Read the following warning notice carefully, before operating the EDC Plus: WARNING •

Never touch parts in the electronic drawer. There is a danger to get an electrical shock even when the EDC Plus is switched off. Some components of the EDC Plus, like the ventilator and transformer, are operating with 220 to 240 V.

•

A damaged EDC Plus is a safety hazard. Switch off at the mains immediately and call technician authorized by Olympus.

•

Installation, commissioning, disposal, changes or alterations of the EDC Plus must only be performed by technicians authorized by Olympus.

•

Decontaminate the EDC Plus before disposal done by Olympus representative (refer to chapter 6).

•

Connect the EDC Plus to a protectively earthed socket with a 16 A building fuse. The protective earth socket must be easy accessible for the user in case of an emergency.

•

Connect the EDC Plus to a medical compressed air or compressed dry air connection.

•

Do not spray the EDC Plus with water for cleaning purposes.

•

Do not pull the open door. The EDC Plus could tip over or could be damaged.

•

Take care when using aggressive detergents (refer to chapter 6).

NOTICE •

Observe the warnings and cautions of the EDC Plus given in each chapter.

•

The safe and reliable functioning of the EDC Plus cannot be assured if the regular intervals for maintenance are not adhered to chapter 6.

•

Regular yearly maintenance of the EDC Plus is strongly recommended to ensure optimal drying results (EDC Plus with expansion twice a year).

•

Regular monitor and complete document the drying process.

•

Use only genuine Olympus accessories with the EDC Plus. Consult Olympus on the type and application of such accessories.

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2.4 Product liability

The manufacturer only assumes liability for the safety, reliability and performance of the EDC Plus if: • Installation/assembly, expansion, readjustments, maintenance, alterations or repairs are performed by authorized technicians. • Install the EDC Plus in rooms fitting electrical with the relevant standards or equivalent European regulations or local regulations applicable to such installations (refer to chapter 9). • Use the EDC Plus according to the instructions given in these instructions for use. WARNING Risk of injury to the patient Assure correct processing and document the test results.

NOTICE Olympus has intensively checked the material compatibility and hygienic efficiency when drying Olympus endoscopes. Olympus guarantee only the material compatibility of Olympus endoscopes. To dry endoscopes by other manufacturers, ask the respective endoscope manufacturer. NOTICE Changes of color can occur on control elements and/or supply connectors but will not cause any malfunctions of endoscopes. Olympus does not held liable for any changes of color.

2.4.1 EN 16442:2015 “Controlled environment storage cabinet for disinfected thermolabile endoscopes” This European standard specifies the performance requirements applying to cabinets designed to dry and store thermolabile endoscopes following automated or manual reprocessing. The cabinet is not intended to provide any cleaning or disinfection function. The EDC Plus is compliant with EN16442:2015.

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Product description

Up to 16 endoscopes can be dried and stored simultaneously in the EDC Plus with expansion unit. If an endoscope has no internal channels, the endoscope is stored and dried by the air circulation in the cabinet.

3.1 General description

The EDC Plus ensures rapid and effective fully automatic drying and storing up to 16 flexible endoscopes. The following models are available: • Model B: Basic version • Model D: Advanced version For each model the following types are available: • Core unit for 4 endoscopes • Core unit for 8 endoscopes • Expansion unit for 8 endoscopes • Expansion unit for 4 endoscopes Pressurized medical grade air or compressed dry air with low content of oil and humidity provided to the endoscope channels allows quick drying (refer to section 3.2). A microelectronic control unit ensures fully automatic process control and monitoring. HEPA filtered ambient air ensure the outer surface drying of the endoscope and create an overpressure in the EDC Plus (refer to section 3.2). Documentation with database or printer connection allowed by the TCP/IP (Ethernet) interface of the EDC Plus (refer to chapter 5). Multi-color touch panel indicates the status of each endoscope: • Drying (blue) • Storage (green) • Error (red) Multi-color LED at each endoscope position indicates the status of each endoscope and has the same color scheme as on the touch panel. • •

Blue, permanent: Blue, flashing:

• •

Green: Green flashing:

•

Red:

•

White:

EDC Plus Instructions for use Version 4.00

Endoscope drying Advanced drying mode, no airflow during drying for a better drying result Endoscope is dry and ready for use (storage) ECO Mode, no airflow during storing to reduce the amount of dry air Alarm concerning the endoscope (refer to local SOP, Standard Operating Procedures) Indicates the preferred position of the endoscope

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Transparent safety glass doors to guarantee the complete visibility and safety for users. Endoscope holders with new ergonomic shape ensure easy and fast placement of different kind of flexible medical endoscopes. Endoscope adapters for each endoscope are directly connected to the endoscope holders. Easy cleaning based on round corners and even surfaces of the EDC Plus. EDC Plus accessories to protect the endoscope and related accessories (refer to chapter 8) EDC Plus model D is equipped with: • RFID reader (user and endoscope identification, refer to chapter 5) • Documentation function (refer to chapter 5) • Electromagnetic door locks (opening by user identification) NOTICE For RFID reader user cards and external endoscope transponders are required. Contact your local Olympus representative.

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EDC Plus Instructions for use Version 4.00

3.2 Working principal of drying

The endoscope drying is based on the moisture absorbing air fed to the EDC Plus. Two different air streams are distinguished in the EDC Plus itself: •

Airflow to endoscope channels Endoscope channel drying with compressed medical grade air or compressed dry air with low content of oil and humidity: This air is blown through the internal channels of the endoscope. Residual water is absorbed by dry air and transferred outside. Additionally, the airflow through the channels has a mechanical effect. Water residuals are pushed out. The process of channel drying takes two hours. After the drying process has been completed, the endoscope can be stored for up to 28 days. The storage time is adjustable to a maximum of 999 hours (refer to local guidelines).

•

Airflow to chamber Drying of the outer surface of the endoscope by filtered ambient air: The EDC Plus is equipped with an integrated ventilator. The air flow created by the ventilator is passing a HEPA sterile air filter (H13) before it enters the chamber of the EDC Plus. This is creating an overpressure in the EDC Plus chamber and the air is discharged through the EDC Plus base (doors). The high air flow volumes inside the chamber prevent air from the environment to enter the cabinet. This air stream absorbs the residual water from the outer surfaces of the endoscopes.

The drip tray at the base of the EDC Plus collects the water droplets blown from the endoscope.

3.3 Default settings The EDC Plus will be delivered with default settings. The settings can be changed according to national and local guidelines and as well in consultation with the local responsible hygienists: Settings Drying time Storage time Door open time

Time

Default

2h

Maximum

999 h

Default

168 h

Maximum

999 h

Default

5 min

Table 3.1: Default and maximum settings of EDC Plus

The settings can be changed, which must be done by an authorized technician. NOTICE The drying time settings can vary due to national requirements and test conditions for monitoring the drying efficacy of the cabinet.

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3.4 Delivery content

Look carefully whether all articles are included in the delivery of the EDC Plus (refer to table 3.2). Inspect each article for damage. If an article is damaged, a component is missing or there are any questions, do not use the EDC Plus and get in contact an Olympus representative. EDC Plus core unit

Delivery content

EDC Plus expansion unit

4 endoscopes

8 endoscopes

4 endoscopes

8 endoscopes

Door handles Drip tray Y-shape clamping pieces Triangular key for top and back access

1 1 3

2 1 6

1 1 3

2 1 6

1

1

1

1

Key for technical area

1

1

-

-

Silica gel grains (1 tin) Wall attachment without screws

1 1

1 2

1

2

Power cord

1

1

-

-

Air supply hose, Ø 8mm (1,5 m)

1

1

-

-

EDC Plus instructions for use Allen screw M6 Spring washer M6 Toothed lock washer M5 Nut M5 Hose clamp

1 -

1 -

1 4 4 2 1 1

1 4 4 2 1 1

Table 3.2: Delivery content of the different EDC Plus types

3.5 Accessories

The following items can be used with the EDC Plus and must be purchased separately if required. Refer to chapter 8 and contact an Olympus representative: • Adapter sets for endoscope channel drying (refer to EDC Plus adapter manual) • Holder for endoscopes without universal cord to dry and store these endoscopes in the EDC Plus (refer to EDC Plus accessory manual) • Holder for bronchoscopes to dry and store these endoscopes in the EDC Plus (refer to EDC Plus accessory manual) • Small instrument baskets to store small endoscope accessories like valves close to each endoscope (refer to EDC Plus accessory manual) • Large instrument basket to store all endoscope accessories at one place(refer to EDC Plus accessory manual) • Holders for second endoscope connectors (refer to EDC Plus accessory manual) • Y-shape clamping pieces for endoscopes with long insertion tube (refer to EDC Plus accessory manual) • RFID tag (refer to section 5.1) • RFID card (refer to section 5.2) • Label printer, OD9 or STAR printer (refer to section 5.5) • Expansion units for 4 or 8 additional endoscopes (refer to section 3.6.1) • Air drying unit, ADU Plus, to dry compressed technical air (refer to ADU Plus instructions for use) • Documentation software, Endobase and DocuSoft (refer to section 5.4) 12

EDC Plus Instructions for use Version 4.00

3.6 Construction of the EDC Plus

The control unit with the touch panel is located on the right-hand side of the EDC Plus core unit. The control unit include the technical area which is locked by a key and must be entered only by authorized technician. The technical area can slide in and out of the control unit by removing the front plate. The touch panel can be turned upwards to access the HEPA filter and the ventilator (authorized technician only). The generated airflow goes from the top to the base of the cabinet and passes thereby endoscopes. When the doors are open, the ventilator runs on a higher speed producing more airflow into the EDC Plus chamber to press the air out of the chamber, reducing the risk of contamination. The drip tray at the base of the EDC Plus collects the water droplets blown from the endoscope (refer to figure 3.2).

1

1

2

2

3

3

4

4

5

5

6

6

7

7

8

8

Figure 3.1: EDC Plus core unit for 8 or 4 endoscopes, front view

1) 2) 3) 4) 5) 6) 7) 8) EDC Plus Instructions for use Version 4.00

Wall attachments Electromagnetic door locks (model D) or magnets (model B) HEPA filtered air system (part of the control unit) Touch panel RFID reader (model D only) Key lock of technical area Door handles Control unit (technical area)

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1

2 3

4 5

6

1

Figure 3.2: Chamber of the EDC Plus core unit for 8 endoscopes

1) 2) 3) 4) 5) 6)

1

Electromagnetic door locks (model D) or magnets (model B) Window to connect an EDC Plus expansion unit to control unit Multi-color LED and lighting Endoscope holder Connection for endoscope adapters Drip tray

2

3

4

5

1) Service area 2) Medical dry air connection 3) Power supply connection 4) Network connection 5) Control unit (technical area) Figure 3.3: EDC Plus core unit for 8 endoscopes, top view

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EDC Plus Instructions for use Version 4.00

3.6.1 EDC Plus expansions The EDC Plus expansion units with a capacity for 4 or 8 endoscopes can be connect to the EDC Plus core unit and allows a high modularity. Connect only same models (B or D) with each other.

Figure 3.4: EDC Plus core unit for 4 endoscopes connected to an EDC Plus expansion unit for 4 endoscopes

Figure 3.5: EDC Plus core unit for 8 endoscopes connected to an EDC Plus expansion unit for 4 or 8 endoscopes

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4 Use 4.1 Connecting the adapter to the EDC Plus A set of dedicated adapters is available for connecting Olympus endoscopes. The adapters are not part of the delivery and must be ordered separately for each endoscope (refer to EDC Plus adapter manual). For more details about dedicated adapters, refer to the section 8.5, the EDC Plus adapter manual or contact an Olympus representative. To connect the adapter on the holder, push the nipple into the connector. To disconnect the adapter on the holder, push the ring upwards. The connection nipple loosens.

Holder disconnect

Connector

Nipple connect

Endoscope adapter

Figure 4.1: Nipple and connector

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EDC Plus Instructions for use Version 4.00

4.2 Preparing endoscopes for EDC Plus WARNING Risk of injury to the patient Do not place endoscopes which are not cleaned and disinfected in the EDC Plus. Follow instructions of the endoscope manufacturer and the washer-disinfector manufacturer. Cross contamination occurs when insufficiently processed endoscopes are placed into the EDC Plus. Endoscopes that have been processed in a washer-disinfector with integrated drying function (like Olympus ETD4 or Olympus ETD Double) and with activated drying stage can be placed directly in the EDC Plus because the endoscope channels have been cleared from residual water. This allows a free passage of air during drying and storage in the EDC Plus. Blow pressurized medical grade air through endoscope channels that have been reprocessed manually or in a washer-disinfector without drying function before placing the endoscope in the EDC Plus. Use an air pistol and flush air for a few seconds through every endoscope channel. Check for remaining water in the channels. Residual water inside endoscope channels can prevent the required amount of air flow through the endoscope channels. WARNING Risk of injury to the patient Remove the water resistant cap from endoscopes before placing the endoscope in the EDC Plus. Check the endoscope channels for blockages before hanging the endoscope in the EDC Plus. NOTICE If the endoscope was processed in a washer-disinfector with flow control that detects blockages of the channels the user check is automatically performed by the washer-disinfector.

4.3 Inserting the endoscopes into the EDC Plus (model B) 1) Open the door 2) Hang the endoscope on the endoscope holder (desired or preferred position) in the EDC Plus. The endoscope holder moves downwards and indicates the presence of an endoscope. Make sure that the correct adapter for this endoscope is on this position. 3) Connect the adapter to the endoscope. Therefore, refer to the EDC Plus adapter manual or contact a local representative. The connection must be tight. 4) Close the door. The EDC Plus blows air through the endoscope channels. When the flow inside the endoscope is within the pre-set limits, the drying process starts automatically. A blue bar appears on the touch panel to indicate that the drying process has started. The remaining drying time is displayed above the blue bar. Above the endoscope, a multi-color LED lights up in blue.

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4.4 Inserting the endoscopes into the EDC Plus (model D) 1) Hold the RFID card in front of the RFID reader and check on the touch panel the user details. 2) Open the door. 3) Hold the RFID tag of the endoscope in front of the RFID reader. Check on the touch panel the details and preferred position of the endoscope. For the preferred position, the corresponding indication LED lights up in white above the preferred position. 4) Place the endoscope on the endoscope holder (desired or dedicated position) in the EDC Plus. The endoscope holder moves downwards and indicates the presence of an endoscope. Make sure that the correct adapter for this endoscope is on this position. 5) Connect the adapter to the endoscope. Therefore, refer to the EDC Plus adapter manual or contact a local representative. The connection must be tight. 6) Close the door. The EDC Plus blows air through the endoscope channels. When the flow inside the endoscope is within the pre-set limits, the drying process starts automatically. A blue bar appears on the touch panel to indicate that the drying process has started. On top of the bar, the remaining drying time is displayed. Above the endoscope, a multi-color LED also lights up in blue. WARNING Risk of injury to the patient Check that all channels of the entire endoscope are correctly connected. For further details, refer to EDC Plus adapter manual or contact a local representative.

4.5 Removing the endoscope from the EDC Plus (model B) 1) 2) 3) 4)

Open the door. Disconnect the endoscope from the adapter. Remove the endoscope from the EDC Plus. Close the door.

4.6 Removing the endoscope from the EDC Plus (model D) 1) Hold the RFID card in front of the RFID reader and check on the touch panel the user details. 2) Open the door. 3) Disconnect the endoscope from the adapter. 4) Remove the endoscope from the EDC Plus. 5) Close the door.

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EDC Plus Instructions for use Version 4.00

4.7 Touch panel

The main screen on the touch panel shows all necessary information. Numbers 1 to 16 are the endoscope positions showing whether the endoscope is connected and the configured drying time (blue) or storage time (green). 2 3

1

4

5

7 6

8

Figure 4.2: Main screen of the touch panel of an EDC Plus core unit for 8 endoscopes connected with an expansion unit for 8 endoscopes

1) Current process values (temperature, humidity and pressure) and status of the cabinet doors (open or closed) 2) Current date and time 3) Remaining time until drying (blue) or storage (green) is finished, in hours (h) or minutes (m). “ALARM” indicates excided storage time or an error. 4) Process bars indicates the status of the endoscopes drying and storage process: • Blue: Endoscope is drying. • Green: Endoscope is dry and ready for use (storage). • Red: There is an alarm with the endoscope. If the storage time is expired refer to local guidelines and standard operating procedures. 5) Endoscope position at the EDC Plus core unit, push the number to access to the position information 6) User which is logged in by User card 7) Door lock open (model D only) 8) Access to keypad for user log in with access code. Access to service menu.

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4.7.1 Endoscope information Tap on the number of an endoscope position. The touch panel shows now all the details about the endoscope, the user, the drying and storage parameters at this position.

1

2

3

Figure 4.3: EDC Plus position information, drying process (process bar: blue)

1) Position:

20

Endoscope position in the EDC Plus showing the drying, storage, user and endoscope information Remaining drying time:

Remaining time until the endoscope drying is finished

Remaining storage time:

Remaining time until the endoscope storage time expire

Current flow:

Air flow through the endoscope channels in lpm

Current valve position:

Shows if the valve is open or closed. Valve regulates the air flow through the endoscope channels • 0%: The valve is closed. No air flow through the endoscope channels • >0%: The valve is open. Air flow through the endoscope channels.

Started on:

Date and time when the endoscope was placed in the EDC Plus EDC Plus Instructions for use Version 4.00